By Lee Sutton and Scott Emery, Thermo Fisher Scientific
Like any biologic, the number one priority with cell and gene therapies during transportation is maintaining the integrity of the drug as well as ensuring it arrives on time to its destination and within temperature specification. The task of maintaining speed, temperature, and integrity becomes much more complicated with these drugs, as many gene therapies are moved at a minimum of minus 80 degrees Celsius, while many cell therapies are moved at cryogenic temperatures, which can be as low as minus 196 degrees Celsius.
In addition to these strict temperature and timing requirements, cell and gene therapy supply chains are more complicated than traditional life science supply chains. Coordination challenges exist in the manufacturing process, especially for autologous therapies, given the highly personalized nature of the medicine itself. It is essential to quickly and efficiently move material to meet the needs of often extremely ill patient populations. This includes ensuring sufficient supply and storage conditions for raw materials, collection and transportation of apheresis or other patient-derived starting material, and final distribution back to patient.
Maintaining temperatures for cold chain drugs requires strict coordination of the supply chain to ensure the material arrives on time to its destination and within specification. Therefore, developing a strong supply chain both in terms of the raw material up front and the ultimate distribution of your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.